Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Recruiting now · Phase 2
Conditions studied: Esophageal Squamous Cell Carcinoma (ESCC)
In brief
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
Key facts
- Study ID
- NCT07559045
- Run by
- Second Affiliated Hospital of Zunyi Medical University
- People needed
- 92
- Starts
- 2026-01-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
- Measurable or evaluable disease per RECIST 1.1
- Willing to provide written informed consent
You may not qualify if…
- Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
- History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
- Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
- Pregnant or lactating women
- Participation in another clinical trial within 30 days prior to randomization
Where it is running
- The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province — Zunyi, Guizhou, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.